Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
Cetuximab Beta Group:Cetuximab beta plus concurrent chemoradiotherapy (CCRT)
Sponsors
Huaihe Hospital Of Henan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, regardless of gender; 2. Histopathologically confirmed unresectable Stage III-IVA head and neck squamous cell carcinoma (HNSCC) (according to AJCC 9th Edition TNM staging criteria); 3. Scheduled to undergo radiotherapy as part of treatment; 4. No prior treatment with anti-EGFR monoclonal antibodies (e.g., cetuximab, panitumumab); 5. Karnofsky Performance Status (KPS) score >= 70; 6. Adequate bone marrow reserve and organ function, as evidenced by the following laboratory values: Complete blood count (CBC): Absolute neutrophil count (ANC) >= 1.5×10^9/L Platelet count >= 100×10^9/L Hemoglobin >= 90 g/L Liver function: Total bilirubin = 60 mL/min (calculated by Cockcroft-Gault formula) Urinalysis showing urine protein = 2+) Coagulation profile: International normalized ratio (INR) or prothrombin time (PT) <= 1.5×ULN For patients on anticoagulant therapy, PT must be within the therapeutic range of the anticoagulant regimen; 7.Women of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose, with a negative pregnancy test prior to treatment initiation; 8.Male participants must agree to use effective contraception during the study and for 6 months after the last dose. 9. All subjects must provide written informed consent before study enrollment, including signature and date on the consent form
Exclusion criteria
Exclusion criteria: 1.Current participation in another therapeutic/interventional clinical trial. 2.History of malignancies other than HNSCC (except cured carcinoma in situ of the cervix, basal cell carcinoma, or other cancers with =5-year disease-free survival). 3.Concomitant severe medical conditions, including but not limited to:Uncontrolled congestive heart failure (NYHA Class III or IV)Unstable anginaPoorly controlled arrhythmiasModerate-to-severe hypertension (SBP >160 mmHg or DBP >100 mmHg), Active infections ,Poorly controlled diabetes mellitus,Psychiatric disorders affecting informed consent and/or complianceHIV infection,Other conditions deemed by investigators to compromise study participation. 4.Prior systemic chemotherapy or anti-EGFR therapy (except postoperative adjuvant treatment). 5.Prior radiotherapy to the target area (except postoperative adjuvant treatment). 6.Known hypersensitivity to anti-EGFR antibody preparations. 7.Pregnancy or lactation. 8.Investigators’ judgment of clinical/laboratory abnormalities or other reasons making the subject ineligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year progression-free survival rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;Disease-Free Survival ;Locoregional Control Duration;Overall Survival; | — |
Countries
China
Contacts
Public ContactLu Hong
Huaihe Hospital Of Henan University
Outcome results
None listed